Sequential, Multiple Assignment, Double Randomized Preference, Migraine Behavioral Trial
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
This study will unpack the behavioral intervention for migraine and determine the optimum combinations. In addition, the study will test preference and self-selection effects during the trial.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
have chronic migraine for a minimum of 1-year
aged 18 years and older
Disqualifiers
secondary headache disorders
children younger than 18 years old
Trial design
Design model
Sequential
Treatments tested in this trial
Migraine Behavioral Treatment
BehavioralMigraine Behavioral Treatment involving daily activities
Treatment groups
24 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Random - MEActive comparator 1 intervention
Group B: Random - MSActive comparator 1 intervention
Group C: Random - SEActive comparator 1 intervention
Group D: Choice - MEActive comparator 1 intervention
Group E: Choice - MSActive comparator 1 intervention
Group F: Choice - SEActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility in terms of recruitment and adherence rates
recruitment rate, adherence rate
Time frame
12 weeksSecondary outcomes
1
Migraine Frequency
migraine day frequency
Time frame
at baseline 4 weeks before randomization, week 2-6 after date of randomization, week 8-12 after date of randomization2
Headache Self-efficacy
headache self-efficacy measured using validated headache self-efficacy questionnaire
Time frame
at baseline 4 weeks before randomization, week 2-6 after date of randomization, week 8-12 after date of randomization3
Migraine Intensity
migraine intensity, self-reported
Time frame
at baseline 4 weeks before randomization, week 2-6 after date of randomization, week 8-12 after date of randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Mayo Clinic
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: